Phase II Study of Ivonescimab Combined With TROP2 ADC for Treating Brain Metastases in Triple-Negative Breast Cancer

What this Trial Is About

Brain metastasis is a common and serious complication for patients with triple-negative breast cancer (TNBC), leading to poor survival outcomes with a median overall survival of less than 6 months. This study explores the use of a new combination treatment involving ivonescimab and TROP2 antibody-drug conjugates (ADCs), like sacituzumab govitecan, aiming to improve treatment outcomes specifically for TNBC patients with brain metastases. Recent advances in immunotherapy and targeted therapies have shown promising results in metastatic TNBC, making this study important to evaluate these therapies in brain metastasis cases. Participants will receive ivonescimab at a dose of 20 mg/kg intravenously every 3 weeks, combined with sacituzumab govitecan at 10 mg/kg intravenously on days 1 and 8 every 3 weeks. Treatment will continue until disease progresses, intolerable side effects occur, participants withdraw consent, or the investigator decides to stop treatment. This is a single-arm, phase II trial conducted at one center to assess the safety and effectiveness of this combined therapy specifically in brain metastases of TNBC. During the study, patients will be closely monitored with MRI to assess brain lesions and other evaluations to track treatment response and side effects. The primary outcome is the intracranial objective response rate measured up to about 12 weeks. Before treatment, participants must provide tissue samples for molecular analysis. Safety and efficacy data will be collected throughout the treatment period, with ongoing assessments to ensure participant well-being and study compliance.

BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC